The post holder will be responsible for and expected to carry out the following duties:
Establish and lead the organization’s Quality and Regulatory Compliance strategy, ensuring alignment with corporate objectives and industry best practices.
Serve as a trusted advisor to the President and senior leadership on quality, compliance, and risk-related matters.
Provide executive-level reporting on compliance risks, audit outcomes, and quality performance metrics.
Oversee and continuously enhance the Quality Management System (QMS), including CAPA, deviations, change control, and internal audit programs.
Ensure adherence to FDA regulations, cGMP, and other applicable U.S. regulatory standards.
Establish enterprise-wide quality standards and ensure consistent implementation across all operations and partners.
Lead and oversee all regulatory compliance activities, ensuring ongoing adherence to applicable laws, regulations, and industry standards.
Act as the primary point of contact for regulatory inspections, audits, and compliance inquiries.
Monitor and interpret changes in regulatory requirements, ensuring timely implementation across the organization.
Ensure continuous inspection readiness and successful audit outcomes.
Proactively identify, assess, and mitigate enterprise-level quality and compliance risks.
Develop and implement policies, procedures, and internal controls to ensure full regulatory and corporate compliance.
Oversee private label generic contracts, ensuring compliance with regulatory and quality standards.
Partner with Supplier Operations to ensure all suppliers meet quality and compliance requirements, including audits and performance monitoring.
Lead, mentor, and develop a high-performing Quality & Compliance team.
Foster a culture of accountability, continuous improvement, and compliance excellence.
Promote cross-functional collaboration to embed quality and compliance into all business processes.
Bachelor’s degree in a relevant field (e.g., Quality Assurance, Compliance, Pharmaceutical Sciences).
6–8 years of experience in Quality and Compliance roles, preferably in the pharmaceutical or healthcare industry.
5+ years of leadership experience managing teams and enterprise-level initiatives.
Deep knowledge of U.S. regulatory requirements (FDA), cGMP standards, and compliance frameworks.
Proven experience managing regulatory inspections, audits, and compliance programs.
Strong understanding of quality systems, risk management, and supplier oversight.
Exceptional leadership, communication, and stakeholder management skills.
Ability to operate at both strategic and operational levels within a complex, regulated environment.
